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PubMed1992

Evaluation of an absorbable suture for sternal closure in pediatric cardiac surgery.

We conducted a study in a prospective fashion using 1-mm diameter absorbable sutures (polydioxanone [PDS]) for sternal closure in 50 consecutive patients, ages 5 months to 16 years, weighing 5 to 27 kg. Good wound closure and absence of any iatrogenic complications were noted. Potential benefits of this approach include disappearance of sequelae of the closure and better bone healing. This appears to be a safe alternative to standard sternotomy closure.

Child↗
PubMed2000

Ligating clips for three-dimensional MR angiography at 1.5 T: in vitro evaluation.

Artifact size on three-dimensional (3D) magnetic resonance (MR) angiograms and safety of various vascular clips (15 titanium and three absorbable polydioxanone clips) were assessed. All evaluated clips were completely safe. Biodegradable clips rendered no artifacts; titanium clips were associated with susceptibility effects. Artifact size was dependent on clip size, clip orientation, echo time, and degree of k-space coverage. In the presence of titanium vascular clips, fast 3D MR angiography should be performed with the shortest echo time and full k-space coverage.

Artifacts↗
PubMed2000

Bioartificial cartilage.

Cartilage is a highly differentiated tissue. Its three-dimensional composition of cells and matrix is able to resist intensive mechanical loads. The capacity of cartilage tissue for regeneration is limited. Chondrocytes are responsible for matrix production of cartilage tissue. Enzymatic isolation and expansion of chondrocytes with cell culture techniques has been improved in the last years. These cells can be cultured on different three-dimensional culture systems suitable for transplantation to repair localized cartilage defects. Two types of bioresorbable polymer fleece matrices (PLLA and a composite fleece of polydioxanone and polyglactin) and lyophilized dura as a biological carrier are tested. Phenotypic and morphological appearance of the cultured articular rabbit chondrocytes is preserved on all three types of transport media. Production of glycosaminoglycans has been shown by Alcian blue staining, production of collagen by azan staining. Chondroitin 4- and 6-sulfate are detected immunohistochemically in the created constructs. The different carriers have specific characteristics regarding their suitability for the creation of bioartificial cartilage. This tissue is transplantable into articular cartilage defects and could, therefore, improve the minor intrinsic healing capacity of cartilage tissue.

Animals↗
PubMedDate not supplied

Influence of suture material and technique on end-to-end reconstruction in tracheal surgery: an experimental study in sheep.

Resection and end-to-end anastomosis of the trachea represent the preferred treatment for various benign and malignant diseases involving the trachea. Various studies have reported conflicting results with alternative techniques and suture materials for tracheal anastomosis. Our objective was to evaluate three frequently used techniques concerning stenosis rate and histological reaction in a large-animal species. Tracheal resection of 3 cm and end-to-end anastomosis were performed in 15 sheep with the use of three different techniques. In the first group, an interrupted suture with polyglactin, in the second group an interrupted suture with polydioxanone, and in the last group a continuous suture with polypropylene were used. The animals were killed 1, 2, 4, 8, and 24 weeks postoperatively. The luminal stenosis was determined by means of computerized planimetry. All three techniques appeared to be appropriate for tracheal anastomosis. The luminal stenosis developed within the first 8 weeks after surgery. A cross-sectional area of approximately 40-70% was finally achieved. Differences dependent on the suture material are less important than the technical details of the operation.

Anastomosis, Surgical↗
PubMed2004

Suture materials: do they affect fistula and stricture rates in flap urethroplasties?

INTRODUCTION: The effect of suture materials on urethroplasty complications is debated. Indeed, materials with a delayed absorption might either reduce the incidence of fistulas by ensuring a prolonged approximation of neo-urethral edges or increase the risk of urethral strictures due to a prolonged tissue reaction during suture absorption. We retrospectively evaluated the role of suture materials in the complication rate of urethroplasty procedures performed in our institution over a 10-year period. PATIENTS AND METHODS: Three hundred and thirty-six boys undergoing a flap procedure (parameatal based, preputial tube, or onlay preputial flap) for hypospadias repair were considered for this study. The patients were stratified into two groups according to the suture material used for urethroplasty. Polyglactin (Vicryl), a polyfilament with intermediate absorption, was used in 254 group A patients, whereas polydioxanone (PDS), a monofilament with prolonged absorption, was used in 82 group B patients. The success of a one-stage repair and stricture and fistula rates were evaluated. RESULTS: A successful one-stage repair was achieved in 82% of the group A and in 83% of the group B patients (p = 0.97). No statistically significant differences were noted in fistula and/or stricture rates in the two groups, even considering each procedure separately. CONCLUSIONS: This series suggests that suture materials do not affect the complication rate in flap urethroplasty procedures. Appropriate technique, meticulous surgery, and surgeon experience seem to be more crucial factors. A randomized trial is warranted.

Child↗
PubMed1983

Behaviour of synthetic absorbable sutures with and without synergistic enteric infection.

The behaviour of synthetic absorbable sutures, polyglycolic acid (PGA) and polydioxanone (PDS), has been tested in an experimental guinea pig model utilising synergistic enteric bacteria. Braided PDS gave a wound sepsis rate of 42%, monofilament PDS 36%, and PGA 26%, while sepsis rate in the controls was 30%. The dissolution characteristics of PGA and monofilament PDS appeared to be unaffected by the presence of infection, while that of braided PDS was significantly increased. Braided PDS also showed more rapid dissolution characteristics than PGA.

Animals↗
PubMed2001

Biocompatibility evaluation of dura mater substitutes in an animal model.

Dura-Guard Dural Repair Patch, PRECLUDE Dura Substitute, and Codman ETHISORB Dura Patch were evaluated in a six-month dural tissue reaction study in rabbits. Bilateral craniotomy was followed by subdural implantation for each dura mater substitute. The surgical procedure for the sham control group was the same except that no material was implanted. Implantation of all of these dura mater substitutes for 28, 91, or 182 days post-implantation did not result in any deaths or clinical neurobehavioral abnormalities, changes in cerebrospinal fluid, or significant macroscopic changes at necropsy. However, histomorphologic evaluation of the implantation sites revealed some differences in the tissue response to these materials. For Dura-Guard Dural Repair Patch, a nonabsorbable material derived from bovine pericardium, the implantation site was characterized by fibrosis of the overlying area with islands of osseous metaplasia and adhesions to the brain surface. Over time, infiltrative fibrosis of the implant resulted in separation of the collagenous layers of the implant and compression of the underlying brain. Fibrosis of the overlying area that incorporated this material formed a 'replacement' dura mater. Adhesions to the brain surface observed initially were still present at six months post-implantation. Implantation of PRECLUDE Dura Substitute, a nonabsorbable material comprised of expanded polytetrafluoroethylene, resulted in virtually no early reaction, and few adhesions to the brain surface at any time period. Although this material was eventually incorporated by fibrosis, islands of osseous metaplasia were also observed in this 'replacement' dura mater. The tissue reaction to Codman ETHISORB Dura Patch, an absorbable material comprised of polyglactin 910 and polydioxanone, was generally characterized by low-grade granulomatous inflammation and initial adhesions to the brain surface. The three-dimensional structure of this implant acted as a scaffold to guide the development and integration of a 'replacement' dura mater. The absorption of the material was associated with complete resolution of the inflammatory reaction, a lack of cerebral adhesions, and restoration of the normal architecture of this region. In conclusion, subdural implantation of Dura-Guard Dural Repair Patch, PRECLUDE Dura Substitute, or Codman ETHISORB Dura Patch in rabbits for up to six months resulted in the eventual restoration of the dura mater without significant adverse effects. However, osseous metaplasia associated with nonabsorbable Dura-Guard Dural Repair Patch and PRECLUDE Dura Substitute, and the infiltration of Dura-Guard Dural Repair Patch by fibrosis suggests that long-term follow-up may be needed after the use of these materials in patients. An advantage of Codman ETHISORB Dura Patch was that it was completely absorbed after guiding the restoration of the dura mater without any morphological sequelae.

Absorbable Implants↗
PubMed1997

Bioartificial nerve grafts based on absorbable guiding filament structures--early observations.

Gaps 10 mm wide in the sciatic nerves of 64 rats were bridged by bioartificial nerve grafts consisting of a silicone tube containing seven longitudinally placed filaments made of non-absorbable, (polyamide [Ethilon]) or absorbable, material (polydioxanone [PDS], polyglactin [Vicryl], and catgut). The purpose was to study the organisation of axonal growth inside the tube along such filaments. After two and four weeks histological techniques were used to study the contents of the tube and at four weeks immunohistological techniques were used to confirm the presence of axons distal to the tube. In all experimental groups axons had traversed the tube and reached the distal segment after four weeks. Inside the tube axons were organised in multiple minifascicles in all groups, but there were no axons growing in direct contact with the filaments. We conclude that resorbable filaments placed inside a silicone tube do not disturb axonal growth across the tube.

Absorption↗
PubMed1998

Histological findings in guided bone regeneration (GBR) around titanium dental implants with autogenous bone chips using a new resorbable membrane.

The aim of this study was to test the value of the new polydioxanone-membrane (PDS, Ethicon, Norderstedt, Germany) in combination with autogenous bone as a spacer for guided bone regeneration of denuded implant surfaces compared to simple augmentation. Forty implants were selected for 20 test cases (with membrane) and 20 control cases (without membrane) and were distributed randomly in 19 patients who were treated according to a standard protocol and examined. The defects were filled with autogenous bone chips, harvested interforaminally or locally, and were covered by the PDS membrane within the test group (control group: periosteum). The membranes were fixed with Memfix screws and cover screws. Seven membranes became exposed and were removed before reentry. Within the control group, three augments were sequestered. After 6 months, reentry was performed, the healing results were observed clinically, and biopsies were taken. The test group, including the seven cases with early removal of the membrane, showed that bone had filled in the defects in 95% of test cases, compared with 60% for the control group. The results of this study show that single augmentation of defects exceeding 9 mm2 is not sufficient. The membrane used in this investigation may be helpful for guided bone regeneration (GBR) at denuded screw thread sites in implant dentistry.

Adult↗
PubMed1999

Comparison of arcuate-legged clipped versus sutured hepatic artery, portal vein, and bile duct anastomoses.

Attempts at improving anastomoses have included the development of stapling techniques. Our purpose was to evaluate arcuate-legged clipped versus standard sutured anastomoses of the hepatic artery (HA), portal vein (PV), and bile duct in a porcine liver transplantation model. Two groups of pigs were studied intraoperatively and 1 day after liver transplantation. A control group underwent sutured anastomosis of PV and HA with polypropylene and of bile duct with polydioxanone (n = 8). An experimental group underwent anastomoses with arcuate-legged clips (n = 8). We analyzed the time to perform anastomosis and flows before and at various time points after anastomosis. In addition, patency and histology of the anastomoses were evaluated 1 day after operation, including a fibrin-thrombosis score, medial injury, and inflammation score. Times to complete HA and PV anastomoses were not different between clipped and sutured groups. However, the time was shorter to complete bile duct anastomosis with clips than with sutures (6.3 +/- 1.1 minutes and 13.3 +/- 2.0 minutes, respectively). Flows through HA anastomoses were not different between groups, but flow through the PV was higher in clipped compared with sutured anastomosis (P = 0.06). Patency was 100 per cent with no leaks for all three anastomoses in both groups. Histologic data were similar between vascular anastomotic groups. Sutured bile duct anastomoses revealed mild smooth muscle injury in 75 per cent whereas clipped bile duct anastomoses displayed no smooth muscle injury. We conclude that arcuate-legged clipped anastomosis represents a viable option to sutured anastomoses of the PV, HA, and bile duct anastomoses. Bile duct anastomoses were completed in less than half the time and with less tissue damage documented histologically.

Anastomosis, Surgical↗
PubMed1999

[Isolated fractures of the orbital floor. Conclusions of a retrospective study of 85 cases].

UNLABELLED: We present a retrospective study of 85 patients presenting an isolated orbital floor fracture between 1993 and 1997; 79 of them (93%) were operated via a subciliary or transconjunctival approach. Surgical procedure included autologous graft or biomaterial (coral, polydioxanone) depending on the cases. The study was focused on clinical data (concerning diplopia, enophthalmia and sensorial disturbances) which were recorded pre- and post-operatively. RESULTS: 58 patients (68%) had a pre-operative diplopia, and 9 (11%) had a persistent post-operative diplopia: all of these patients were operated more than 8 days after trauma; no post-operative diplopia occurred without pre-operative diplopia; 8 patients (9%) presented a pre-op enophthalmia: all of them came more than 10 days after the trauma; a perfect symmetry was obtained post-operatively in only one of these 8 patients; no enophthalmia occurred in patients without pre-op enophthalmia; sensorial disturbances were seen pre-operatively in 27 patients (32%) and post-operatively in 17 (20%); no correlation was found with the timing or the procedure of the surgery. COMMENTS: The interest of an early diagnosis and treatment is confirmed, in order to avoid late functional (diplopia) or esthetic (enophthalmos) disturbances. Thus it seems necessary to obtain a computed tomography for any orbital trauma as conventional radiography can be less sensitive. Concerning the surgical procedure, resorbable biomaterials seem to be very well tolerated and easy to use. Autologous bone grafts always lead to a certain degree of morbidity without real advantage. The best way seems to be the trans-conjonctival approach, but subciliary incisions can also be used in these cases. The most important remaining problem to solve is probably focused on sensorial disturbances: their incidence is high and there is a high rate of sequels: further studies are obviously necessary to improve the knowledge of etiopathogenic factors and determine the best therapeutic attitude.

Adolescent↗
PubMed2000

Bioabsorbable plates and screws: Current state of the art in facial fracture repair.

BACKGROUND AND OBJECTIVES: The use of bioabsorbable materials in craniomaxillofacial surgery began a new era in fracture fixation. The purpose of this paper is to review the historical perspectives and the current concept of bioresorbable materials in fracture fixation. METHODS AND MATERIALS: The authors review the biochemistry and clinical characteristics of bioabsorbable polymers--polylactic acid (PLA), polyglycolic acid (PGA), polydioxanone (PDS), and their copolymers. Their use and clinical perspectives by the Helsinki (authors') group and other study groups are presented. RESULTS AND CONCLUSIONS: These materials have proven to be safe in clinical applications. When manufactured with current technology, they are easy to handle. Economically, they are nearly equal to similar metal devices. The materials have met clinical success throughout the world, first in orthognathic surgery, followed by treatment of fractures of the upper facial skeleton and the mandible. Today, most maxillofacial fractures and osteotomies may be adequately fixed with bioabsorbable materials.

Absorbable Implants↗
PubMed2002

Repair of flexor tendon defects of rabbit with tissue engineering method.

OBJECTIVE: To repair rabbit tendon defects with tissue engineering method. METHODS: The third passage of fetal skin fibroblast cells was labeled with 5-bromo-2' deoxyuridine (Brdu) and then seeded on human amnion extracellular matrix (HA-ECM). Using 1 cm-long-Achilles tendon defects as repairing models in the experimental group, tendon defects were core bridged with polydioxanone (PDS) and then capsulated with the complex of fibroblasts-HA-ECM. In the control group I, defective tendons were sutured with PDS following the former procedure and capsulated with HA-ECM (without fibroblasts). In the control group II, only PDS was applied to connect the defective tendons. Gross examination, light microscopy, scanning electronmicroscopy and biomechanical measurement of the repaired tendons were respectively performed at postoperative 1, 2, 3 month as well as immunohistochemical examination. RESULTS: The optimal cell concentration for seeding fibroblasts was 3.5 x 10(6) cells/ml. Cells grew well and radiated or paralleled on HA-ECM. Immunohistochemistry showed that the labeled seed fibroblasts played an important role in tendonization. The results of light microscopy, electron microscopy, and biomechanical assessment suggested that the rate and quality of tendonization in the experimental group was superior to those of the control group I and II. The tensile strength in the experimental group was the greatest, the next was in the control group I, and the worst in the control group II (P<0.05). CONCLUSIONS: HA-ECM is the excellent carrier for fibroblasts. Fibroblasts-HA-ECM complex has the capability to repair tendon defect and to tendonize with rapid rate and good performance three months after operation. Its tensile strength is 81.8% of that of normal tendon.

Amnion↗
PubMed1992

[The use of different suture materials in thyroid surgery. A statistical evaluation of the immediate and long-term results].

Six groups of patients for a total of 120 cases were examined for cervical wound suture results. Different synthetic absorbable sutures and different suture techniques were employed. Good aesthetic results were always obtained in long-term follow-up. The patients sutured with Polydioxanone, a monofilament with prolonged breaking strength retention, had a lower incidence of local complications.

Absorption↗
PubMed1992

[Stabilization of the injured shoulder joint with PDS cord].

A successful treatment of the acromioclavicular separation is the repair of the acromioclavicular and coracoclavicular (CC-)ligaments and a stable reduction of the acromioclavicular (AC-)joint. To avoid dangerous breakage and migration of the K-wire an abduction humeral splint is necessary immobilizing the injured shoulder for 5-6 weeks. In the years 1987-1989 40 patients suffering AC-separation were treated (34 Tossy III separations, 4 Tossy II separations, 2 Tossy I separations). In these cases a stable reduction was achieved by a transarticular K-wire fixation and a combination of AC- and CC-fixation by loops. In 1987 wire loop was used. In 1988 a combination of wire and Polydioxanon (PDS) loops was used. The PDS-loop, a slowly resorbable suture material, fixed the CC-ligament. In 1989 the AC-joint was stabilized by a PDS-loop as well. The examination of 31 patients 6-24 months after the operation showed good clinical results no matter whether PDS-loops or wire loops were used. The advantage of the transarticular K-wire fixation in combination with PDS-loops was the easy removal, which could be done in mostly of the cases as an outpatient procedure. An operation of the AC-Tossy III separation on patients beyond their 4. decade should be well considered. A long time of treatment, remaining pain and a limitation of shoulder movement must be expected.

Acromioclavicular Joint↗
PubMed1992

[Long-term results of the Blalock-Taussig shunts].

One-hundred and thirty-six patients received the classical Blalock-Taussig shunts between 1980 and 1990. Their age range at operation was 4 days to 12.8 years and their median age was 13 months. The operative mortality rate was 0.7% (1/136). The survivors were followed up from 1 month to 11.5 years, 5.4 years in average. Twenty-five patients required another shunt and the mean interval to that procedure was 2.4 years (modified Blalock-Taussig 23, classical Blalock-Taussig 2, Glenn 1, internal mammary artery-pulmonary artery shunt 1). Forty-five patients received corrective operations, there were four operative deaths (Fontan 2, Rastelli 2). There were 15 late deaths of which three deaths were not cardiogenic. One year after operation, 91.0% of patients remained in well-palliated condition. At three years after operation, 76.4% of patients continued to be in well-palliated condition. There were twelve neonates in this series. Their age range was 4 to 26 days and their median age was 13 days. There was no operative death. Five patients required second shunt. There were two late deaths. At present, six patients continue to be in well-palliated condition 8 months to 9 years after first operation. Angiographic findings showed the stenotic change of the vascular anastomoses in 49.3% (35/71) of patients. This study suggests that polydioxanone suture (PDS) will be useful for the growth of the anastomoses in Blalock-Taussig operation.

Anastomosis, Surgical↗
PubMed2003

The short-term results of internal carotid reconstructions by absorbable suture material.

Analysis was made of the results of 11 internal carotid reconstructions using polydioxanone (PDS) sutures 6 months after intervention performed in 10 patients. All operations on the carotid bifurcation were accomplished using 5/0 PDS continuous suture. Nine eversion carotid endarterectomies and 2 internal carotid reconstructions were performed for Kinkiking. There were no neurologic complications, thromboses, bleedings or repeated operations after interventions on the brachiocephalic arteries. Six months later the patients were examined under ambulatory conditions and were provided color duplex scanning (CDS) of the reconstructed area. Measurements were made of the diameter of the common carotid artery (CCA) right beneath the anastomosis between the CCA and the internal carotid artery (ICA), of the maximal diameter of the anastomosis between the CCA and the ICA, and of the size of the proximal ICA segment right the anastomosis. During the 6-month period following surgical intervention, all 10 patients did not demonstrate any ischemic attacks (TIA) or strokes. No cases of anastomotic aneurysms were recorded. After 9 reconstructions no ICA restenoses were marked. In one case, restenosis accounted for 40% because of atherosclerosis progression and after one operation there developed asymptomatic thrombosis of the ICA. The study has demonstrated that the use of PBS absorbable suture for autoarterial ICA reconstruction provides for anastomosis integrity minimally over the period as long as 6 months.

Absorbable Implants↗
PubMed2004

[Evaluation of sternal deformity after pediatric minimally invasive cardiac surgery].

Sternal shape is one of the most important esthetic factors of the chest appearance after pediatric minimally invasive cardiac surgery (pMICS) as well as length of skin wound. We evaluated the grade of postoperative sternal deformity in 20 patients who underwent total repair of pediatric congenital heart disease [atrial septal defect (ASD): 17, ventricular septal defect (VSD): 2, partial anomalous pulmonary venous connection (PAPVC): 1] with minimal skin incision and lower partial median sternotomy. The sternum was closed with stainless wire in 3 patients, with absorbable polydioxanone (PDS) cord in 5 patients, with combined use of reabsorbable radiolucent poly (L-lactate) acid sternal pin and absorbable PDS cord in 12 patients. The evaluation of postoperative sternal deformity was made according to the vertebral index (VI) and frontosagittal index (FSI) in 3 groups with each sternal closure method. VI and FSI of the 3 groups showed no significant difference. Sternal deformity in the group with sternal closure with PDS cord group was more severe than that in other 2 groups. The combined use of sternal pin with PDS cord offered the most sufficient fixative strength for sternal closure.

Absorbable Implants↗